LAST WEEK TODAY!

A summary of what was published on ProstateWarriors.com during the past week

Hi fellow warriors! Another week full of interesting and promising clinical trials! The approaches are multiplying, and immunotherapies are advancing even for prostate cancer, which is beginning to respond. Stay strong and fight on!

As usual, we also have a podcast if you prefer to listen to the newsletter, you can find it HERE.
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Clinical Research

• Phase 3 Trial: CAPItello-281 (Capivasertib + Abiraterone)
  ​The CAPItello-281 study demonstrates that combining capivasertib with abiraterone and ADT significantly improves outcomes for patients with PTEN-deficient mHSPC. The trial met its primary endpoint of radiographic progression-free survival (rPFS), showing a median of 33.2 months compared to 25.7 months for the placebo group. Despite a higher rate of adverse events, patient quality of life remained stable, with most patients continuing treatment without erosion of physical or functional wellbeing.​
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• Phase 3 Trial: PEACE-3 (Radium-223 + Enzalutamide)
  ​The final results of the Phase 3 PEACE-3 trial indicate that adding radium-223 to enzalutamide significantly extends overall survival for men with mCRPC and bone metastases. The combination increased median overall survival to 38.2 months, compared to 32.6 months with enzalutamide alone, and improved median rPFS to 19.2 months. This regimen is considered a potential new standard for bone-dominant disease, as radium-223 targets bone metastases via calcium mimicry while enzalutamide addresses systemic progression.​
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• Phase 2 Trial: Co-PSMA (Cu-64 SAR-bisPSMA)
  ​The Co-PSMA trial revealed that 64Cu-SAR-bisPSMA is a superior next-generation PET imaging agent, more than doubling the detection of prostate cancer lesions compared to the standard 68Ga-PSMA-11 in patients with biochemical recurrence. It achieved a positive scan rate of 78%, and its 12.7-hour half-life allows for optimized next-day imaging with higher tumor contrast. These results suggest it could represent a major shift in diagnostic standards for early detection, guiding more effective salvage therapy.​
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• Phase 1/2 Trial: AM006 (HER2 FPBMC)
  ​The AM006 clinical trial evaluates HER2 FPBMC, an immunotherapy where a patient’s own T cells are activated and armed with a bispecific antibody to target HER2-positive tumors. This approach targets the 20-30% of metastatic prostate cancer cases that overexpress HER2, showing evidence in lab models of significantly higher tumor-killing ability than unarmed cells. Early human data indicates manageable side effects and initial signals of tumor shrinkage and PSA declines in some metastatic castration-resistant prostate cancer (mCRPC) cases.​
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• Phase 1/2 Trial: PARTHENON (AZD4956)
  ​The PARTHENON trial investigates AZD4956, an oral drug that blocks the SMARCA2 protein to target cancers with homologous recombination deficiency (HRD). By shutting down SMARCA2 in tumors that already struggle to repair DNA, the therapy aims to induce “synthetic lethality,” specifically for the 20-30% of mCRPC cases harboring HRD signatures like BRCA mutations. The study is testing the drug both as a monotherapy and in combination with the PARP1 inhibitor saruparib.​
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• Phase 1 Trial: P-PSMA-101 CAR-T Therapy
  ​The phase 1 trial for P-PSMA-101 explores an autologous CAR-T cell therapy for heavily pretreated mCRPC patients. While the treatment involved notable toxicities, including cytokine release syndrome in 61% of participants, it also showed promising anti-tumor activity, with 21% of patients achieving a ≥50% PSA decline. The therapy demonstrated bone-tropic behavior and led to disease stabilization or imaging improvements in a subset of patients who had failed up to ten prior standard treatments.​
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• Phase 1 Trial: SYS6043 (B7-H3 ADC)
  SYS6043 is a novel antibody-drug conjugate (ADC) designed to target B7-H3, a protein highly expressed in advanced prostate cancer but rare in healthy tissue. The drug attaches to the protein, enters the cancer cell, and releases a topoisomerase I inhibitor to destroy the cell’s DNA. This trial is currently assessing the safety and dosing of SYS6043, specifically focusing on mCRPC patients with bone-only disease who may have failed previous treatments like taxanes or PARP inhibitors.​
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• Complete Response to Pembrolizumab in a Metastatic Prostate Cancer Case​
  A remarkable case study highlights a patient with metastatic, castration-resistant prostate cancer who achieved a complete and durable response to pembrolizumab. The patient’s tumor had rare molecular features, including MSI-H, dMMR, and high TMB, which made it highly sensitive to immunotherapy after standard treatments had failed. Although such cases occur in well under 1% of advanced prostate cancers, this patient remained progression-free for more than four years with an undetectable PSA and no evidence of disease on imaging.​
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Preclinical Research & Reviews

• Ah! Not this week! But there will be something interesting soon.
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And…that’s all folks! For today at least!
Please let me know if there is anything I can improve in my newsletters, and let me know if you have enjoyed the podcast.

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Have a great weekend!

Max